Extractables & Leachables Qualification of the Primary packaging for Biological Products

Benefit from our Unmatched Experience!

The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be largely realized with minimal adverse patient effects. However, since the practical reality is that drug products and medical devices contain impurities, a patient is exposed to these impurities during treatment and these impurities could potentially trigger an increase of adverse patient effects.

Nelson Labs Europe’s capabilities are complementary and additive to Nelson Labs’ existing testing portfolio and, in combination, makes Nelson Labs one of the premiere global E&L laboratory testing platforms for the pharmaceutical and medical device industries.

In this webinar, originally broadcast as part of the Pharmapack Europe show, Piet Christiaens, Scientific Director, Nelson Labs talks about the Universe of Extractables and how there are many different types of materials being used in the construct of a Container system. The impurities profile of a material is typically composed of compounds that were intentionally added to a material to protect the material during production or its life cycle or to increase performance or functionality. In this case, he is talking about polymer additives. However, there is even a longer list of compounds that are present in a material that were not intentionally added. These compounds have been introduced during the production process of the material, or they are the result of ageing of the material. The presentation will give an overview – for the most common materials used in the construct of container/closure systems or medical devices – of the main classes of compounds that are often detected in extractable studies.

When selecting and qualifying the Primary Packaging for lyophilized drug products, one of the obvious questions is “how deep should one go into the E/L-qualification process of a lyo-container”. As the drug product is in a solid state, it is expected that the interaction between the lyophilized drug product and the components of a lyo-container will be low. This is also reflected in the USP Monograph on Leachables and the EMA Guideline on “Plastic Immediate Packaging Materials” (2005). However, the mechanism of interaction between the lyo-cake and e.g. the rubber stopper (when considering a lyo vial) are not always fully understood. The interaction mechanism is based upon “outgassing” of the rubber stopper, where the lyo cake acts as an adsorbent. Not only can this lead to substantial accumulation of the volatile and semi-volatile leachable compounds onto the lyophilized drug product, it may also induce chemical reactions between the leachables and the drug product, i.e. when the adsorbed leachables show electrophilic properties. When you attend this webinar, you will have: A thorough understanding of the interaction mechanisms between a lyophilized drug product and it's container. An understanding of an Extractables and Leachables study design for a lyophilized drug product